FDA 510(k)

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

N.º K: K250070 · 2026-06-26

SolicitanteShenzhen Changkun Technology Co., Ltd.

Fecha de decisión2026-06-26

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K250070. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)?

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K250070.

When did Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) receive FDA 510(k) clearance?

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K250070.

Who is the listed applicant for Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)?

The FDA 510(k) record lists Shenzhen Changkun Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)?

The FDA product code for Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) is HGX.

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Otros registros que enlistan a Shenzhen Changkun Technology Co., Ltd. como solicitante

K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)K231595Electric Breast Pump K221798Finger Pulse Oximeter, Model: X1906P K193386Wrist Electronic Sphygmomanometer K193387Esfigmomanómetro Electrónico de brazo K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

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Dispositivos relacionados (Código: HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.